Allergic Bronchopulmonary AspergillosisNCT05129033
A Prospective Study on Optimizing Treatment for ABPA
A study testing Prednisone tablet, itraconazole and Omalizumab in people with Allergic Bronchopulmonary Aspergillosis, run by Shanghai Zhongshan Hospital.
Trial summary
This study is being done to evaluate the efficacy of treatment using oral glucocorticoid, anti-fungal agent, anti-IgE mAb for patient with ABPA. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis
- What is being tested?
- Prednisone tablet, itraconazole and Omalizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18~75 years old, male or female
- associated past medical history, including asthma, bronchiectasis, COPD ect.
- elevated serum total IgE (>100IU/mL)
- elevated aspergillus specific IgE
Who cannot join
- According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness).
- Pregnancy or breastfeeding
- Abnormality of liver or kidney function
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Two-center, Clinical Study to Optimize the Treatment for Allergic Bronchopulmonary Aspergillosis (ABPA)
This study is being done to evaluate the efficacy of treatment using oral glucocorticoid, anti-fungal agent, anti-IgE mAb for patient with ABPA.
Read the detailed description
This is a study randomly treating ABPA patients with either anti-fungal agent plus OCS or anti-IgE mAb (omalizumab) plus OCS.
OCS is the basic treatment for ABPA by suppressing allergy and inflammation. Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to for a total usage of 6 months. Reduction may failed if disease exacerbate.
Anti-fungal agent (mainly itraconazole) could reduce the load of fungus but its application is still controversial. The investigators use itraconazole 200mg bid for 8 months and 100mg bid for another 8 months.
Omalizumab was given 600mg q4w for at least 6 months. The investigators use Anti-fungal agent and Omalizumab as a supplement to OCS to evaluate the better treatment plan for ABPA patients.
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Being tested
- Prednisone tablet, itraconazole, Omalizumab
- Keywords
- Allergic Bronchopulmonary Aspergillosis, anti-fungal agent, Omalizumab, oral corticosteroids
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone tabletDrug
Basic medication for allergic airway inflammation such as asthma and ABPA, to relieve inflammation. Reduction may failed if disease exacerbate.
itraconazoleDrug
Anti-fungal medication to reduce fugal load.
OmalizumabBiological
Anti-IgE monoclonal antibody, used for high IgE allergic disease.
| Study group | Role | What they receive |
|---|---|---|
| anti-fungal agent plus OCS | Active comparator | Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to stop for a total usage of 6 months Itraconazole is given orally 200mg bid for 8 months and 100mg bid for another 8 months Receives: Drug: Prednisone tablet; Drug: itraconazole |
| anti-IgE mAb plus OCS | Active comparator | Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to stop for a total usage of 6 months Omalizumab is given by subcutaneous injection of 600mg q4w for at least 6 months Receives: Drug: Prednisone tablet; Biological: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index
the exacerbation times indicated by symptoms and clinical index, including commom respiratory symptoms such as wheezing, cough, expectation, dyspnea and so on. As well as new shadows in chest CT. Those situation may cause the extreme clinic visit and hospitalization, which could be measured by times or days.
Measured: Up to 6 months after last treatment dose
Secondary outcomes (2)
ST.George's respiratory questionnaire
The SGRQ is a classic respiratory questionnaire including the symptoms, activity, and impact to life. The higher score means better disease control.
Measured: Up to 6 months after last treatment dose
asthma control test questionnaire
The ACT is a classic asthma questionnaire recommended by GINA (Global Initiative for Asthma). ACT mainly measures the symptoms. The higher score means better disease control.
Measured: Up to 6 months after last treatment dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start15 Nov 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Allergic Bronchopulmonary AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meiling Jin, MD, Study chair, Department of Respiratory, Zhongshan Hospital, Fudan University Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129033
- Sponsor's protocol ID
- 2020ZSLC26
- Status last verified
- Nov 2021
- First submitted
- 3 Jul 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agarwal R. Allergic bronchopulmonary aspergillosis. Chest. 2009 Mar;135(3):805-826. doi: 10.1378/chest.08-2586.
PubMed 19265090Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Aspergillus hypersensitivity and allergic bronchopulmonary aspergillosis in patients with bronchial asthma: systematic review and meta-analysis. Int J Tuberc Lung Dis. 2009 Aug;13(8):936-44.
PubMed 19723372Agarwal R, Nath A, Aggarwal AN, Gupta D, Chakrabarti A. Aspergillus hypersensitivity and allergic bronchopulmonary aspergillosis in patients with acute severe asthma in a respiratory intensive care unit in North India. Mycoses. 2010 Mar 1;53(2):138-43. doi: 10.1111/j.1439-0507.2008.01680.x. Epub 2009 Jan 24.
PubMed 19207831Agarwal R, Chakrabarti A, Shah A, Gupta D, Meis JF, Guleria R, Moss R, Denning DW; ABPA complicating asthma ISHAM working group. Allergic bronchopulmonary aspergillosis: review of literature and proposal of new diagnostic and classification criteria. Clin Exp Allergy. 2013 Aug;43(8):850-73. doi: 10.1111/cea.12141.
PubMed 23889240Mou Y, Ye L, Ye M, Yang D, Jin M. A retrospective study of patients with a delayed diagnosis of allergic bronchopulmonary aspergillosis/allergic bronchopulmonary mycosis. Allergy Asthma Proc. 2014 Mar-Apr;35(2):e21-6. doi: 10.2500/aap.2014.35.3731.
PubMed 24717781Agarwal R, Gupta D, Aggarwal AN, Saxena AK, Chakrabarti A, Jindal SK. Clinical significance of hyperattenuating mucoid impaction in allergic bronchopulmonary aspergillosis: an analysis of 155 patients. Chest. 2007 Oct;132(4):1183-90. doi: 10.1378/chest.07-0808. Epub 2007 Jul 23.
PubMed 17646221
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Two-center, Clinical Study to Optimize the Treatment for Allergic Bronchopulmonary Aspergillosis (ABPA)
- ClinicalTrials.gov ID
- NCT05129033
- Acronym / sponsor ID
- 2020ZSLC26
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Keywords
- Allergic Bronchopulmonary Aspergillosis, anti-fungal agent, Omalizumab, oral corticosteroids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to evaluate the efficacy of treatment using oral glucocorticoid, anti-fungal agent, anti-IgE mAb for patient with ABPA.
Detailed description
This is a study randomly treating ABPA patients with either anti-fungal agent plus OCS or anti-IgE mAb (omalizumab) plus OCS.
OCS is the basic treatment for ABPA by suppressing allergy and inflammation. Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to for a total usage of 6 months. Reduction may failed if disease exacerbate.
Anti-fungal agent (mainly itraconazole) could reduce the load of fungus but its application is still controversial. The investigators use itraconazole 200mg bid for 8 months and 100mg bid for another 8 months.
Omalizumab was given 600mg q4w for at least 6 months. The investigators use Anti-fungal agent and Omalizumab as a supplement to OCS to evaluate the better treatment plan for ABPA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-fungal agent plus OCS | Active comparator | Drug: Prednisone tablet, Drug: itraconazolePrednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to stop for a total usage of 6 months Itraconazole is given orally 200mg bid for 8 months and 100mg bid for another 8 months |
| anti-IgE mAb plus OCS | Active comparator | Drug: Prednisone tablet, Biological: OmalizumabPrednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to stop for a total usage of 6 months Omalizumab is given by subcutaneous injection of 600mg q4w for at least 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18~75 years old, male or female
- associated past medical history, including asthma, bronchiectasis, COPD ect.
- elevated serum total IgE (>100IU/mL)
- elevated aspergillus specific IgE
Key exclusion criteria (3 listed)
- According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness).
- Pregnancy or breastfeeding
- Abnormality of liver or kidney function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone tabletBasic medication for allergic airway inflammation such as asthma and ABPA, to relieve inflammation. Reduction may failed if disease exacerbate. | Drug | anti-IgE mAb plus OCS, anti-fungal agent plus OCS |
| itraconazoleAnti-fungal medication to reduce fugal load. | Drug | anti-fungal agent plus OCS |
| OmalizumabAnti-IgE monoclonal antibody, used for high IgE allergic disease. | Biological | anti-IgE mAb plus OCS |
Primary outcome
incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index
Time frame: Up to 6 months after last treatment dose
the exacerbation times indicated by symptoms and clinical index, including commom respiratory symptoms such as wheezing, cough, expectation, dyspnea and so on. As well as new shadows in chest CT. Those situation may cause the extreme clinic visit and hospitalization, which could be measured by times or days.
2 secondary outcomes
ST.George's respiratory questionnaire
Time frame: Up to 6 months after last treatment dose
asthma control test questionnaire
Time frame: Up to 6 months after last treatment dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Background: PubMed 19265090Agarwal R. Allergic bronchopulmonary aspergillosis. Chest. 2009 Mar;135(3):805-826. doi: 10.1378/chest.08-2586.
- Background: PubMed 19723372Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Aspergillus hypersensitivity and allergic bronchopulmonary aspergillosis in patients with bronchial asthma: systematic review and meta-analysis. Int J Tuberc Lung Dis. 2009 Aug;13(8):936-44.
- Background: PubMed 19207831Agarwal R, Nath A, Aggarwal AN, Gupta D, Chakrabarti A. Aspergillus hypersensitivity and allergic bronchopulmonary aspergillosis in patients with acute severe asthma in a respiratory intensive care unit in North India. Mycoses. 2010 Mar 1;53(2):138-43. doi: 10.1111/j.1439-0507.2008.01680.x. Epub 2009 Jan 24.
- Background: PubMed 23889240Agarwal R, Chakrabarti A, Shah A, Gupta D, Meis JF, Guleria R, Moss R, Denning DW; ABPA complicating asthma ISHAM working group. Allergic bronchopulmonary aspergillosis: review of literature and proposal of new diagnostic and classification criteria. Clin Exp Allergy. 2013 Aug;43(8):850-73. doi: 10.1111/cea.12141.
- Background: PubMed 24717781Mou Y, Ye L, Ye M, Yang D, Jin M. A retrospective study of patients with a delayed diagnosis of allergic bronchopulmonary aspergillosis/allergic bronchopulmonary mycosis. Allergy Asthma Proc. 2014 Mar-Apr;35(2):e21-6. doi: 10.2500/aap.2014.35.3731.
- Background: PubMed 17646221Agarwal R, Gupta D, Aggarwal AN, Saxena AK, Chakrabarti A, Jindal SK. Clinical significance of hyperattenuating mucoid impaction in allergic bronchopulmonary aspergillosis: an analysis of 155 patients. Chest. 2007 Oct;132(4):1183-90. doi: 10.1378/chest.07-0808. Epub 2007 Jul 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meiling Jin, MD study chair
Department of Respiratory, Zhongshan Hospital, Fudan University Shanghai, China
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone tablet, itraconazole and Omalizumab in people with Allergic Bronchopulmonary Aspergillosis, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meiling Jin, MD (+86 13701640522, mljin118@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index (time frame: Up to 6 months after last treatment dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129033, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.